The present invention relates to the field of ostomy-related devices, and, more particularly, to a system for use by individuals having a stoma or internal reservoir, including those people having a self-retaining ostomy port of the type described briefly below, and in further detail in our pending related U.S. patent application Ser. No. 09/030,685, which self-retaining continent ostomy port can be inserted into a stoma and secured for long-term placement. The new ostomy irrigation system, having a pulsating pump and specialized adapters, permits hands-free drainage and irrigation of the ostomy, as well as portability and connectability to various types of ports and direct delivery of medicaments or other substances through the stoma site, as well as permitting the user to ambulate between the infusion and evacuation steps of the irrigation process.
Surgically formed stomas may be of a variety of types, including, but not limited to, ileostomies, colostomies and urostomies. Although the discussion below will usually describe the invention with reference to the stoma resulting from a colostomy procedure, it is to be understood that the new continent ostomy port can be applied to other types of stomas as well including those interfacing with surgically created internal reservoirs. For simplicity of discussion throughout this document, the term xe2x80x9cstomaxe2x80x9d will be understood to include stomas emanating from internal reservoir structures as well as normal, intact bowel. Ostomates, individuals who have a stoma, have historically been faced with a variety of problems not ordinarily experienced by the general (non-ostomate) public. Many of these problems are associated with the appliances (i.e. pouches/bags) these individuals are required to wear to manage their surgically created incontinence. These bags surround the outlet to the surgically created stoma and are attached to the individual""s abdomen via adhesives, belts or tapes. They provide a container into which fecal matter can continuously drain. Problems associated with these bags include seepage of intestinal gas and waste, such as mucous and liquid and solid fecal material from around the pouch seal. Such seepage not only causes unpleasant and embarrassing odors, but also leads to health and hygiene problems, such as fecal soiling, skin irritation or worse, necrosis of the tissue surrounding the stoma site. This tissue necrosis creates the additional problems of increased expense and increased health risks as a result of the treatment or surgical intervention required to repair the damaged tissue. The bag material can also make bothersome noises during movement as the bag rubs against the user""s clothing. For many ostomates, the bulk of the bag beneath clothing also presents a problem. All these negative consequences of having an ostomy can deter social activities of all types, and especially any which are more physical in nature. Frequently, isolation and depression result.
Despite the problems associated with conventional ostomy bags, it is to be understood that the new ostomy ports described herein are capable of accepting an ostomy bag or other accessories adapted to connect to the opening of the new ostomy ports, preferably in detenting and at least substantially leak-proof fashion. Purposes for using a bag with the new ostomy ports include but are not limited to: providing a new user a method of gradually weaning themselves from the use of an ostomy bag and providing a method of temporary collection for a user with a high output ostomy, in instances when they will not be able to get to a toilet facility for an extended period of time.
Additional problems with conventional ostomy systems include allergic reactions to the bag material and/or adhesives used to affix the bag to the abdomen. Both problems can be eliminated by the proposed system which eliminates the long-term need to wear an ostomy bag. It is conceivable, however, that the ostomy ports described herein which are intended primarily to be used without adhesives, could in fact be used with an adhesive, particularly if the new ports are made and used without the preferred internal retention bolster or other structure for maintaining the port in normal operative position.
The known commercial art has made a variety of attempts to address these problems, without clinical success. Although the majority of ostomates use bags to manage body wastes, a number of barrier devices have been developed which essentially completely plug or occlude the stoma until the user is ready to evacuate. Total occlusion of the colon results in a number of problems including the build-up of gases resulting in abdominal cramping, leakage around the device, extrusion of the device from the ostomy and pressure necrosis of the intrastomal intestinal tissue. These occlusive devices, for the most part, have not been clinically viable and many have required revisionary surgery in order to function properly. By contrast, the new continent ostomy port which can be placed in existing stomas without surgical intervention addresses all of these problems. The new continent ostomy port continually filters and vents intestinal gas, while preventing the escape of fecal matter. It has a xe2x80x9cbioresponsivexe2x80x9d internal retention bolster that adjusts to changes in intracolonic pressure to simultaneously prevent leakage, tissue necrosis and device extrusion.
Many of these previously attempted and presently marketed barrier devices required the device to be completely removed from the stoma in order for the individual to purge (evacuate) and/or irrigate the bowel. The new continent ostomy port permits quick and facile access for irrigating and/or purging the ostomy without removing the port from the stoma or internal reservoir. These necessary procedures, irrigation and purging, as will be made clear hereafter, are made easier and more convenient by use of the system of the present invention.
Because of limitations of the presently marketed ostomy irrigation sets (i.e. a gravity bag with an attached tubing set that terminates in a conical adapter that interfaces with the stoma), some of the shortcomings of the conventional ostomy irrigation process are the time consuming nature of the process (60-90 min.), the confinement of the user to one place (i.e. the user cannot ambulate) during the process and the requirement that the user hold the cone in place during the infusion portion of the process. Water temperature problems also exist with known systems, as discussed further hereafter.
The new ostomy irrigation system, particularly when used with the described ostomy port, facilitates long-term port access and helps to eliminate the need to continuously wear an ostomy bag and/or the need for cumbersome and lengthy daily irrigation procedures. The long-term access port, described briefly herein (and more completely described and shown in our copending U.S. patent application entitled, Continent Ostomy Port, the specification of which is incorporated herein by reference, in its entirety), prevents leakage sometimes associated with the use of known colostomy management methods because the connection between the new ostomy management system and the user is via this new locking, sealing port which mates internally with the stoma. By contrast, known ostomy management systems conventionally are affixed directly to the stoma site by adhesives or belts, thus permitting leakage because a complete seal at the site of device user interface is not always possible.
The ostomy irrigation system of the present invention is adapted for convenient and facile use in both of the above situations, whether the ostomate is using a conventional ostomy appliance or the new continent ostomy port. The new port device is adapted to be selectively connected to a pouch or tube, as may be necessary from time to time to dispose of waste and to irrigate the intestine for cleanliness and health, while also being capable of being tightly capped for substantial periods of time, even hours, for example, to permit the user to be continent and to have sufficient control to be free to engage in normal physical activities and to function in a wide variety of social settings without fear of leakage and/or embarrassment.
When it is necessary, for ostomates with an ileostomy or wetter colostomies, to void body wastes, simply plugging in a drainage tube adapted to mate with the new port is all that is necessary in the new system for the user to eliminate body wastes directly into a toilet. The tube and connector can easily be carried discretely in a small pouch and cleansed by rinsing with soapy water after use. Such drainage tube and connector are optional elements, which can be included in the new irrigation system or provided separately, and which can be reusable and/or disposable. For ostomates with drier colostomies the new system can be used by pumping fluid into the bowel via a specialized port, trapping the fluid by closing the port, waiting, while either ambulating or resting for a period of time and then draining the bowel contents via a drain tube and adapter described hereafter.
The new system for ostomy/reservoir drainage and automated pumping irrigation is especially beneficial for those ostomates who wish to regulate their bowel evacuation and irrigate their colon instead of wearing an appliance (e.g., ostomy bag) for extended periods of time. The pulsating water delivered by the irrigation pump of the present invention stimulates peristalsis and assists in breaking up and loosening impacted fecal matter, thus dramatically reducing the time required to irrigate an ostomy, as compared to conventional gravity-fed irrigation processes which xe2x80x9cchainxe2x80x9d the user to an unsightly I.V. pole and restrict the ostomate from ambulating during the irrigation process. A further limitation of gravity irrigation systems is their lack of thrust which greatly slows the irrigation process. By contrast, the new system provides programmable-pressurized bursts of pre-warmed irrigation fluid into the bowel to introduce fluid, as well as to stimulate peristalsis. Although the pulsatile fluid delivery of the new system optimizes the irrigation process, it is to be understood that the new ostomy ports described herein are capable of connecting to a xe2x80x9cconventionalxe2x80x9d gravity set or bag by use of a connector designed to interlock with the opening of the port(s), such as in the manner shown for the drainage tubes and irrigation connectors described further herein.
Yet another limitation of conventional gravity irrigation systems is that they allow the irrigation water (or other fluid) to become uncomfortably cool during the irrigation process, as they provide no adaptation by which to alter or maintain the fluid temperature during irrigation infusion. In addition to being uncomfortable, overly cool irrigation fluid is generally considered to be less effective in loosening stool. This shortcoming, over time, ultimately contributes to lengthening the entire irrigation procedure, which is ordinarily reported to take as long as 60 to 90 minutes.
Aesthetically speaking, ostomates often do not like the xe2x80x9chospital-lookxe2x80x9d or clutter of an I.V. pole and irrigation bag in the home, because it serves as a reminder of his or her disorder or disease to friends, family and the ostomate of his or her disorder. Such clinical and cosmetic issues, combined with the long infusion times associated with gravity irrigation systems, have deterred many ostomates from adopting irrigation as an option. As a result, ostomates who may be candidates for using existing barrier devices and eliminating the need for a collection bag, frequently choose to continually wear a collection bag rather than spending up to 90 minutes a day irrigating and evacuating.
The irrigation system of the present invention includes a pump mechanism, which will provide prewarmed irrigation fluid in pressurized bursts (or pulses) into the ostomy. A variety of nozzles connectable to the pump diffuse the fluid into the intestine to ensure gentle yet vigorous infusion of irrigants to maximize the loosening of stool and stimulation of peristalsis. Bowel evacuation of fecal matter and/or irrigation fluid then requires simply disconnecting the irrigation nozzle and connecting a drainage tube to the new port or to the stoma via a temporary ostomy port described below. The opposite end of the drain tube is then positioned to drain into a toilet bowl.
Those ostomates who are unable or uninterested in using the new continent ostomy port (xe2x80x9cCOPxe2x80x9d), but wish to irrigate with the automated irrigation can make use of a new temporary ostomy port (xe2x80x9cTOPxe2x80x9d) that is connectable with other portions of the new irrigation system. The temporary ostomy port preferably includes a balloon actuated internal retention bolster at its distal tip which allows the port to self retain inside the stoma for a hands-free procedure similar to that performed with the long term continent ostomy port. This new temporary ostomy irrigation port is designed to accommodate the variation in abdominal wall thickness that may occur between ostomates. For example, the distance between the stoma-lock balloon and anchoring cone resting on the stoma outside the ostomy can be quickly and easily adjusted by screwing the cone portion down or up the shaft of the port device.
Another feature of the temporary ostomy port is that a substantially liquid-tight cap and anti-reflux valve permit the user to disconnect from the pump portion of the system in order to ambulate or engage in other activities while maintaining the irrigation fluids within the bowel for additional dissolution of the impacted fecal matter. Irrigation connectors and drainage tubes both fit the temporary ostomy port and continent ostomy port interchangeably, for convenience and for manufacturing economies of scale. Similarly, gravity bag connectors and conventional ostomy bags can be adapted to interconnect with the ports of the new system. Further, the new irrigation system, including the pump, are easily transported inconspicuously in a carrying case which can have an appearance much like a computer case, brief case or overnight bag. Thus, the various features and construction of the new irrigation system are highly preferable overall, as compared to known gravity fed ostomy irrigation systems.
In addition to simple gravity fed irrigation systems, other known flushing or irrigation devices, such as that described by Lee et al. (U.S. Pat. No. 5,019,056) and Mead et al. (U.S. Pat. No. 5,190,519), include cumbersome equipment which require the user to have assistance and which take up a great deal of space, being designed primarily for institutional use, rather than residential, and which also requires a great deal of water (for example, five gallons) for the purging process. The use of such large volumes of purging water can upset the user""s electrolyte balance and potentially cause dehydration or other serious health consequences. In addition, the described features of such known devices necessarily entail a great deal of expense. These costs can be avoided with the new system, which is more than suitable for unassisted home use, as it requires only about one half or two liters of water per treatment and the unit is of a size that makes it easily transportable.
Other known purging devices are more of the bidet type and are not suited for specialized locking (detenting) attachment for hands-free use nor are they specifically designed for the irrigation of colostomies or reservoirs. None of the known irrigation or purging devices offer the flexibility for various uses and types of users, as does the present system.
In addition to the various advantages of the present irrigation system mentioned above, the new system can be used to treat pouchitis (inflammation of the surgically created ileo or anorectal pouches (reservoirs) in ileostomies), by using the pump to vigorously infuse irrigants and thereby breakup the stagnation that contributes to pouchitis. Routine careful use of the system in this manner is expected to reduce occurrence of such inflammations.
Other potential uses for the new pump/irrigation system are: (1) radiological diagnostic procedures, wherein the pump is used to infuse radiological agents prior to x-raying the patient""s lower GI tract; (2) treatment for relief of rectal impaction, for which the portable nature of the new system is particularly useful; (3) fluid instillation for enematic purposes; (4) management of incontinence; and (5) to replace gravity bags; i.e., instead of infusing the liquid via gravity through a cone, it can be infused with the new pump system, e.g. through a cone into the stoma or through a new ostomy port. This last procedure may still be of use for certain individuals who desire the pulsation effect, even when the system is used without one of the new ostomy ports. In view of the above, it will be appreciated that a primary advantage of the new ostomy irrigation system, and particularly when used in combination with one of the new ostomy ports, is that there is permitted thereby unique and direct access to the interior of the colon or other stoma site for purposes of diagnosis, observation or treatment.
In view of the various short-comings of the known art, it is among the several goals and advantages of the present invention to provide a system for drainage and irrigation of a stoma, which virtually eliminates leakage of liquid and solid waste from the stoma during drainage and irrigation, and which permits the user to accomplish these time consuming and tedious tasks while still having free use of the user""s hands, except for the brief amount of time required for attaching and releasing quick-connect fittings between the ostomy port and the system.
It is further among the advantages of the present system, having the features discussed, that it permits the user to perform the tasks of ostomy drainage and irrigation in much less time than has previously been possible, with very little training and with little to no assistance. The new irrigation system is also: 1) readily portable; 2) controls temperature, pressure and pulse rate and dwell of irrigation fluid with settings that are customized according to the requirements of the individual user; 3) permits disconnection and ambulation during the irrigation process; and 4) requires only a small volume of irrigation fluid, compared to existing pump irrigation systems.
The user of the new system thus is provided with a generally improved quality of life, including enhanced body image, increased confidence and sexuality, and greater freedom of activity. The psychological stress related to concerns with leakage and odor often encountered when an ostomy bag is worn to collect body waste is virtually eliminated with use of the new system. Generally, the present time related deterent that is discouraging those individuals with colostomies who are candidates for irrigation rather than continually wearing a bag have been eliminated.
The previously mentioned, long term continent ostomy port device is adapted for selective use with the new, specially designed drain tubes, and irrigation sets of the system of the present invention. In addition, some individuals have internal surgically created reservoirs, such as those generally known as Kock and Indiana-type pouches, which, similarly, can be drained and irrigated by the new system. The new ostomy irrigation system is also suitable for use with surgically formed urinary and bowel ostomies, as well as with cecostomies, and gastrostomies, and for decompression as well as irrigation and drainage purposes.
The new system described herein is also convenient and surprisingly useful for delivery of strategic agents, such as therapeutic and diagnostic compounds. These may include detection and screening agents, monitory agents or stimulatives, for example. These substances can be introduced directly into the bowel or other ostomy site via the new port by suspending, mixing or dissolving the selected reagent with the irrigation fluid. Such localized delivery permits direct contact with the intestinal tissue, which can be very beneficial, or even required for some substances which would otherwise be altered if taken by mouth and passed through the upper gastrointestinal tract before reaching the desired target in the intestine or urinary system. Thus, medication may be more effective (i.e. because of local rather than systemic delivery) and tests may be performed which would otherwise be painful, difficult or impossible. Also, localized delivery can eliminate some side effects associated with system delivery.
An improved seal and compatibility with irregularly shaped or contoured stomas is readily accomplished with the new long term continent ostomy port (xe2x80x9cCOPxe2x80x9d), as compared with previously known devices for attachment to a stoma. Such improved sealing is seen even with use of the new port device in ostomates who are elderly or obese, or who have soft or flaccid abdomens. Thus, the new irrigation system described herein, which is designed to adapt especially to the new long term port device as well as the new temporary ostomy port device, is designed to also be useful for such individuals with weak, soft or flaccid abdomens, for convenient, hands-free ostomy drainage and irrigation.
The indwelling nature of the new COP also has advantages for use in small children, because the skin is especially sensitive to the adhesives conventionally used for attaching an ostomy bag to an abdomen. In addition, the hands-free operation of the present system is especially useful in the care of small children. When the care giver must necessarily be occupied with otherwise handling the child, it is appreciated that if irrigation is necessary, manipulation of the drainage and irrigation devices of the new system is minimal and highly controllable as far as temperature and pressure.
The indwelling nature of the new COP is also ideal for ostomates who are undergoing skin-grafting or other abdominally located would healing measures, providing reduction in the otherwise high incidences of necrotizing enterocolitis (xe2x80x9cNECxe2x80x9d) seen in such individuals.
In addition, the indwelling nature of the COP is especially useful in preventing stomal strictures and in improving electrolyte balance in individuals with high output ostomies. The presence of the COP prevents the stoma from collapsing upon itself and the temporary occlusive nature of the COP holds effluent in the ileum longer, thus providing more time for nutrient absorption.
Thus, in furtherance of the above-mentioned goals and advantages, the present invention is, briefly, an ostomy irrigation system which permits independent, hands-free ostomy irrigation by a user having an ostomy or a surgically created reservoir. The system includes a pump unit capable of providing monitored, controlled pulsations of fluid at a volume and pressure suitable for safe and convenient introduction into an ostomy of the user; and a reservoir in fluid communication with the pump unit, at least one irrigation connector set including a tube attachable to the pump unit, and a connector nozzle adapted for selectively releasable, substantially fluid tight interlocking connection with an ostomy port in the ostomy of the user so that the system is effectively closed. Structure is also provided for operating the system such that a user can, without the assistance of others, attach at least one irrigation connector set to the ostomy port in the user""s ostomy and the pump unit and, then without further substantial use of the user""s hands to control the connector or tubing, introduce irrigation fluid into the ostomy in a controlled, safe and convenient manner.
The invention is also, briefly, a method for irrigating an ostomy using the system of the present invention, and a temporary ostomy port which can be used with the system of the present invention.
These and other advantageous features of the present invention will be in part apparent and in part pointed out herein below.